Effects of Topical Fluoride in Orthodontic Patients

NCT07091890 | Active Not Recruiting DMC

• 1 other identifier: 328CET
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study was born from the need to improve caries prevention in orthodontic patients, a group particularly at risk. Fixed orthodontic appliances make daily oral hygiene more difficult, leading to increased plaque accumulation and the proliferation of cariogenic bacteria such as Streptococcus mutans and, more recently, Selenomonas sputigena. Although the latter does not cause cavities on its own, it enhances the action of Streptococcus mutans, making the caries process more aggressive. The aim of the research was to evaluate the effectiveness of two different types of professional topical fluoride-gel and varnish-in reducing the presence of these bacteria and improving certain clinical parameters, such as salivary pH, the DMFT index (which measures decayed, missing, and filled teeth), and the Plaque Control Record (PCR%). The study involved 45 patients, all between 8 and 17 years old and wearing fixed orthodontic appliances. They were divided into three groups: one received fluoride gel, another received fluoride varnish, and the third group underwent only a professional oral hygiene session, without any fluoride application. All patients were evaluated at the beginning of the study (T0) and again after four months (T1), both clinically and microbiologically, through saliva and plaque analysis. The results showed that in the fluoride-treated groups-especially the varnish group-there was a significant reduction in plaque, an improvement in salivary pH (mainly in the gel group), and a decrease in the presence of S. mutans and S. sputigena. Furthermore, there was a reduction in oral Streptococci and Lactobacilli levels in the treated groups, whereas these levels increased in the control group. Interestingly, although not all differences were statistically significant, the improvements observed in the treatment groups suggest a clinically relevant benefit of topical fluoride, especially in varnish form. In conclusion, professional application of fluoride-whether in gel or varnish form-proved effective in counteracting key bacteria responsible for dental caries in orthodontic patients and in improving several relevant clinical parameters. This confirms the importance of combining professional oral hygiene with specific fluoride treatments in patients wearing orthodontic appliances.

Conditions

Topical Fluoride; Orthodontic Patients; Antimicrobial Effect; Clinical Effect

Outcome Measures

Primary Outcomes (2)

• Quantitative evaluation of Streptococcus mutans

  Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)

  T0 baseline, T1 4 months

• Quantitative evaluation of Selemonas sputigena

  Molecular methods Polymerase Chain Reaction - Quantitative Polymerase Chain Reaction (PCR-qPCR)

  T0 baseline, T1 4 months

Secondary Outcomes (3)

• Plaque Control Record

  T0 baseline, T1 4 months

• DMFT

  T0 baseline, T1 4 months

• Salivary ph

  T0 baseline, T1 4 months

Study Arms (3)

Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel

EXPERIMENTAL

Device: Fluoride gel

Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish

EXPERIMENTAL

Device: Fluoride varnish

Professional oral hygiene session alone

NO INTERVENTION

All patients underwent a professional oral hygiene session to remove bacterial plaque and calculus from the tooth surfaces. Bacterial plaque was removed using a supragingival air-polishing device that dispersed glycine powder. When calcified residues were present, a piezoelectric ultrasonic scaler with either a supragingival insert, perio-slim periodontal insert, or scaler was selectively used in cases of deposits in areas that were difficult to access

Interventions

Fluoride gel DEVICE

After non-surgical therapy, 6-8 g of a gel containing 12,500 ppm of fluoride was applied for 4 min using a disposable tray appropriately sized for the patient's mouth. As per the guidelines, the patient was asked to briefly rinse their mouth with water. The aim was to remineralize the dental enamel to make it less susceptible to acid attacks caused by low salivary pH and the byproducts of bacterial metabolism

Professional oral hygiene session and a topical fluoride prophylaxis treatment with gel

Fluoride varnish DEVICE

After non-surgical therapy, a fluoride varnish containing 7,700 ppm of fluoride in a homogeneous solution was evenly distributed over the dental surfaces using a micro-brush. Patients were instructed to spit out excess saliva but not to rinse their mouth with water, and to refrain from eating or drinking for at least 60 min afterward. After drying, the varnish formed a fluoride-rich layer on the enamel, increasing the concentration by up to four times. Despite the high concentration of fluoride, the resin component of the varnish allowed for a slow, controlled release of fluoride over time, thus preventing its immediate loss and minimizing the amount ingested by the patient. The purpose was to prevent mineral loss from the enamel and promote its restoration, making the dental tissue more resistant to the acidic pH of saliva caused by the production of organic acids through bacterial metabolism.

Professional oral hygiene session and a topical fluoride prophylaxis treatment with varnish

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< DMFT \< n-1 (n= number of teeth present in the oral cavity)
• age between 8 and 17 years
• patient wearing fixed orthodontic appliances

You may not qualify if:

• DMFT = 0 \*; professional topical fluoride prophylaxis session carried out in the last 3 months
• patient not wearing fixed orthodontic appliances
• orthodontic treatment already completed or not started \* DMFT refers to a caries prevalence index related to the presence of Decayed, Missing, Filled Teeth due to caries (Decayed, Missing, Filled Teeth).

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Integrated University Hospital Company Verona

Verona, 37134, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 29, 2025
• Study Start: November 16, 2023
• Primary Completion: June 30, 2025
• Study Completion: November 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)